Hepatitis C, Chronic
Conditions
Brief summary
This open-label, non-randomized, single arm study will provide treatment or re-treatment with Pegasys (peginterferon alfa-2a) as monotherapy or in combination with Copegus (ribavirin) to patients with chronic hepatitis C infection. Patients who have received prior Pegasys monotherapy or combination therapy or who were considered eligible for treatment with Pegasys in previous donor protocols will be eligible to participate in this study. Treatment will be on investigator's decision according to the approved label for up to 48 weeks, with a 24-week safety follow-up.
Interventions
DRUGPeginterferon alfa-2a
Both combination and monotherapy for both genotype 2/3 and genotype non-2/3: 180 μg subcutaneously once weekly.
DRUGRibavirin
For genotype 2/3, 800 mg orally daily, in 2 split doses for 24 weeks. For genotype non-2/3, 1000 mg orally daily for participants weighing \< 75 kg or 1200 mg orally daily for participants weighing ≥ 75 kg, in 2 split doses, for 48 weeks.
Sponsors
Hoffmann-La Roche
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult patients, ≥ 18 years of age. * Chronic hepatitis C. * Compensated liver disease (Child-Pugh Class A). * Previous participation in a donor protocol in which treatment or re-treatment with Pegasys alone or in combination with Copegus was recommended or deemed appropriate after study completion. * Have completed safety and efficacy assessments as defined in the donor protocol without violation or any major deviation. * Have not received any other anti-hepatitis C virus treatment after the completion of the donor protocol. * For females of childbearing potential, a negative pregnancy test within 24 hours prior to first dose of study drug. * Fertile patients (male and female) must use 2 reliable forms of contraception (combined) for the duration of the study (treatment and follow-up) in accordance with the locally approved label for Copegus.
Exclusion criteria
* Pregnant or breastfeeding women. * Male partners of women who are pregnant. * Patients with hemoglobinopathies. * Hepatic decompensation (Child-Pugh Class B or C) before or during treatment. * Non-responder patients (defined as patients previously treated with Pegasys and Copegus combination therapy at standard doses for at least 12 weeks who did not achieve at least a 2-log drop from their baseline viral load). * Liver disease other than chronic hepatitis C, including hepatic carcinoma.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of Participants With at Least 1 Adverse Event | From Baseline to the end of the study (up to 72 weeks) |
Countries
Australia, Brazil, France, Greece, Italy, Poland, Puerto Rico, Spain, Taiwan, United Kingdom, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Peginterferon Alfa-2a Monotherapy or Combined With Ribavirin The treating investigator decided the most appropriate treatment. It was recommended that participants receive combination therapy. | 272 |
| Total | 272 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Abnormal Laboratory Test | 1 |
| Overall Study | Administrative/Other | 16 |
| Overall Study | Adverse Event/Intercurrent Illness | 3 |
| Overall Study | Death | 1 |
| Overall Study | Failure to Return | 43 |
| Overall Study | Insufficient Therapeutic Response | 22 |
| Overall Study | Other Protocol Violation | 1 |
| Overall Study | Refusal of Treatment | 1 |
| Overall Study | Withdrawal of Consent | 16 |
Baseline characteristics
| Characteristic | Peginterferon Alfa-2a Monotherapy or Combined With Ribavirin |
|---|---|
| Age Continuous | 48.3 years STANDARD_DEVIATION 9.5 |
| Body Mass Index (BMI) | 28.8 kg/m^2 STANDARD_DEVIATION 5.89 |
| Height | 172.4 Centimeters (cm) STANDARD_DEVIATION 10.22 |
| Race/Ethnicity, Customized Black | 24 Participants |
| Race/Ethnicity, Customized Caucasian | 189 Participants |
| Race/Ethnicity, Customized Oriental | 6 Participants |
| Race/Ethnicity, Customized Other | 53 Participants |
| Sex: Female, Male Female | 90 Participants |
| Sex: Female, Male Male | 182 Participants |
| Weight | 85.72 Kilograms (kg) STANDARD_DEVIATION 19.803 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 39 / 272 |
| serious Total, serious adverse events | 17 / 272 |
Outcome results
Primary
Percentage of Participants With at Least 1 Adverse Event
Time frame: From Baseline to the end of the study (up to 72 weeks)
Population: All participants analysis set.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Peginterferon Alfa-2a Monotherapy or Combined With Ribavirin | Percentage of Participants With at Least 1 Adverse Event | 38.2 Percentage of participants |